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Re: drkazmd65 post# 95876

Friday, 08/01/2014 5:36:32 PM

Friday, August 01, 2014 5:36:32 PM

Post# of 146194
Exactly.

The FDA agrees:

"For a drug to qualify for orphan designation both the drug and the disease or condition must meet certain criteria specified in the ODA and FDA’s implementing regulations at 21 CFR Part 316. Orphan designation qualifies the sponsor of the drug for various development incentives of the ODA, including tax credits for qualified clinical testing."

http://www.fda.gov/forindustry/developingproductsforrarediseasesconditions/howtoapplyfororphanproductdesignation/default.htm

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